Vedolizumab Solution for injection

What is this medicine?

VEDOLIZUMAB (Ve doe LIZ you mab) is used to treat ulcerative colitis and Crohn's disease in adult patients.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• hepatitis B or history of hepatitis B infection

• HIV or AIDS

• immune system problems

• infection or history of infections

• liver disease

• recently received or scheduled to receive a vaccine

• scheduled to have surgery

• tuberculosis, a positive skin test for tuberculosis or have recently been in close contact with someone who has tuberculosis

• an unusual or allergic reaction to vedolizumab, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• steroid medicines like prednisone or cortisone

• TNF-alpha inhibitors like natalizumab, adalimumab, and infliximab

• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Stay away from people who are sick. Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself.

In some patients, this medicine may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your doctor right away. If you cannot reach your doctor, get urgent medical care.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• chest pain

• dark urine

• depression, feelings of sadness

• dizziness

• general ill feeling or flu-like symptoms

• irregular, missed, or painful menstrual periods

• light-colored stools

• loss of appetite, nausea

• muscle weakness

• problems with balance, talking, or walking

• right upper belly pain

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• aches, pains

• headache

• stomach upset

• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.